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Sleep to Prevent Evolving Affecting Disorders (SPREAD)

Primary Purpose

Insomnia, Primary, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dCBTI
Sleep Education
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insomnia, Primary focused on measuring insomnia, depression, digital CBTI, online CBTI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meets Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition(DSMV) criteria for insomnia

Exclusion Criteria:

  • Lack of insomnia, untreated sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome), bipolar disorder, history of seizure disorder, high depression chronicity (self-reported daily or near daily depressed mood and anhedonia)

Sites / Locations

  • Henry Ford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dCBTI

Sleep Education

Arm Description

Online access to the digital CBTI program Sleepio

Weekly email messages with sleep hygiene recommendations

Outcomes

Primary Outcome Measures

Severity of Depression
Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity) and incidence of depression
Prevention of Incident Depression (Post-treatment)
Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)
Prevention of Depression Relapse 1-years Post Treatment
Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)

Secondary Outcome Measures

Severity of Symptoms of Insomnia - Post Treatment
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
Severity of Symptoms of Insomnia - 1 year Post Treatment
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)

Full Information

First Posted
December 7, 2016
Last Updated
October 29, 2018
Sponsor
Henry Ford Health System
Collaborators
Robert Wood Johnson 1R56MH115150-01
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1. Study Identification

Unique Protocol Identification Number
NCT02988375
Brief Title
Sleep to Prevent Evolving Affecting Disorders
Acronym
SPREAD
Official Title
Sleep to Prevent Evolving Affecting Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 8, 2016 (Actual)
Primary Completion Date
April 26, 2018 (Actual)
Study Completion Date
September 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
Robert Wood Johnson 1R56MH115150-01

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of the proposed research is to determine the efficacy of Digital Cognitive Behavior Therapy (dCBTI) in reducing severity of depression and also in preventing the incidence and relapse of depression among insomniacs. In addition, we will identify salient sociological/environmental variables, such as age, sex, education, socioeconomic status (SES), racial/ethnic minority-status, work schedule, child-care responsibilities (i.e., having children under the age of 3), stigma, that moderate the effects of this intervention.
Detailed Description
The purpose of this study is to determine the effectiveness of Digital Cognitive Behavior Therapy for Insomnia (dCBTI) in reducing severity of depression and also in preventing the incidence and relapse of depression among insomniacs. dCBTI is an online form of Cognitive Behavioral Therapy (CBT) used with people who experience trouble sleeping at night (insomniacs). This study will allow us to determine whether this form of digital therapy is helpful in reducing the severity of depression and in preventing the development and relapse of depression in people suffering from insomnia. Participants will be recruited from several well-developed sources, including the HFHS Sleep Center Clinical database. Once a participant meets inclusion criteria and provides consent, a link to the internet portal will be provided to complete the remaining survey questions. After completion of this assessment, participants will be automatically randomized to one of 2 active online insomnia treatment conditions. Each treatment involves 6 weekly "sessions" which each take up to 20 minutes to complete. A post-treatment questionnaire immediately following the 6-week treatment phase will be completed. In addition, a follow up questionnaire assessment will be completed approximately 1 year after treatment. Each of the 3 separate questionnaires will take 20-30 minutes to complete. Participants will be compensated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Primary, Depression
Keywords
insomnia, depression, digital CBTI, online CBTI

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1385 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dCBTI
Arm Type
Experimental
Arm Description
Online access to the digital CBTI program Sleepio
Arm Title
Sleep Education
Arm Type
Placebo Comparator
Arm Description
Weekly email messages with sleep hygiene recommendations
Intervention Type
Behavioral
Intervention Name(s)
dCBTI
Intervention Type
Behavioral
Intervention Name(s)
Sleep Education
Primary Outcome Measure Information:
Title
Severity of Depression
Description
Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity) and incidence of depression
Time Frame
Pre-treatment (Day 1)
Title
Prevention of Incident Depression (Post-treatment)
Description
Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)
Time Frame
Post-treatment (~6 week after Screening)
Title
Prevention of Depression Relapse 1-years Post Treatment
Description
Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)
Time Frame
1-year follow-up (58 week after screening)
Secondary Outcome Measure Information:
Title
Severity of Symptoms of Insomnia - Post Treatment
Description
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
Time Frame
Post-treatment (~6 week after Screening)
Title
Severity of Symptoms of Insomnia - 1 year Post Treatment
Description
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
Time Frame
1-year follow-up (58 week after screening)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition(DSMV) criteria for insomnia Exclusion Criteria: Lack of insomnia, untreated sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome), bipolar disorder, history of seizure disorder, high depression chronicity (self-reported daily or near daily depressed mood and anhedonia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Drake, PhD
Organizational Affiliation
Henry Ford Medical Center - Columbus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34788453
Citation
Cheng P, Casement MD, Cuellar R, Johnson DA, Kalmbach D, Cuamatzi Castelan A, Drake CL. Sleepless in COVID-19: racial disparities during the pandemic as a consequence of structural inequity. Sleep. 2022 Jan 11;45(1):zsab242. doi: 10.1093/sleep/zsab242.
Results Reference
derived
PubMed Identifier
33249492
Citation
Cheng P, Casement MD, Kalmbach DA, Castelan AC, Drake CL. Digital cognitive behavioral therapy for insomnia promotes later health resilience during the coronavirus disease 19 (COVID-19) pandemic. Sleep. 2021 Apr 9;44(4):zsaa258. doi: 10.1093/sleep/zsaa258.
Results Reference
derived
PubMed Identifier
31535688
Citation
Cheng P, Kalmbach DA, Tallent G, Joseph CL, Espie CA, Drake CL. Depression prevention via digital cognitive behavioral therapy for insomnia: a randomized controlled trial. Sleep. 2019 Oct 9;42(10):zsz150. doi: 10.1093/sleep/zsz150.
Results Reference
derived

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Sleep to Prevent Evolving Affecting Disorders

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